3.12.1.8 First Regulatory Approval Date

Date Published

Under sec 70(3), the period beginning on the date of the patent and ending on the first regulatory approval date for the pharmaceutical substance must be at least 5 years.  The first regulatory approval date, in relation to a pharmaceutical substance, is defined in sec 70(5) as:

  • where there is no pre-TGA marketing approval in relation to the substance, the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance; or
  • where there is pre-TGA marketing approval in relation to the substance, the date of the first approval.

Goods may be included in the ARTG as registered goods, provisionally registered goods, listed goods, biologicals or medical devices.  Importantly, not everything that is included in the ARTG will satisfy the other requirements of section 70 (for example, medical devices, or biologicals which are used to replace parts of the anatomy in a person, are unlikely to be considered pharmaceutical substances per se).

‘First inclusion in the ARTG’ means the first time the goods are included in the ARTG, regardless of what part of the register the goods are included in.

Note: ‘Registered goods’ are assessed by the TGA for quality, safety and efficacy.  ‘Listed goods’ are assessed for quality and safety, but not efficacy. ‘Biologicals’ comprise, contain or are derived from human cells or tissues.

While the pharmaceutical substance on which an application for an extension of term is based must in substance fall within the scope of a claim, where the claims encompass more than one pharmaceutical substance, the ‘first inclusion in the ARTG’ refers to the earliest date on which at least one substance falling within the scope of the claims was included in the ARTG.

According to sec 71(2) an application for an extension of term must be made within 6 months of the latest of the date of grant of the patent or the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, any of the pharmaceutical substances referred to in sec 70(3) (see 3.12.2.2).


Case Law

Pfizer Corp v Commissioner of Patents [2006] FCAFC 190

The case concerned 4 patents, each relating to a pharmaceutical substance.  The term of each patent was extended on the basis that the first regulatory approval date was the date on which the relevant pharmaceutical substance was entered into the part of the ARTG relating to registered goods.  However, it was subsequently found that the pharmaceutical substances had previously been entered into the part of the ARTG relating to listed goods.  Consequently, the Commissioner altered the expiry date of the patents to reflect the date of first listing, thereby reducing the lengths of the extensions of term.

The Court considered the issue of whether the first regulatory approval date was the date on which the substance was entered into the part of the ARTG relating to registered goods, or the date on which the substance was entered into the part relating to listed goods.  It was held that the goods in question were first included in the ARTG when they were included in that part relating to listed goods.  Furthermore, there was no error on the part of the Commissioner in treating the first inclusion of the relevant goods in the part of the ARTG relating to listed goods, as the first regulatory approval date of those goods.

Pfizer Italia S.r.l. [2007] APO 2

The patent in question related to a number of pharmaceutical substances.  An extension of term was granted on the basis of one substance, Zavedos.  The patentee subsequently notified the Commissioner that several other pharmaceutical substances claimed in the patent had first regulatory approval dates that were earlier than that of Zavedos.

Under sec 77, the length of an extension of term is equal to the period beginning on the date of the patent and ending on the earliest first regulatory approval date in relation to any of the pharmaceutical substances referred to in sec 70(2), reduced (but not below zero) by 5 years.

It was held that the correct interpretation of sec 77 is that the extension is determined on the earliest first regulatory approval date that applies to the substances in the patent and not only with regard to the substance on which the application for an extension is based.

In this case, the earliest first regulatory approval date was for the substance Adriamycin (13 November 1989) and not Zavedos (19 August 1999).  As a consequence, the extension of term granted according to sec 77 was zero.

G.D.Searle LLC [2008] APO 31

The patentee applied for an extension of term based on the pharmaceutical substance darunavir.  It was subsequently found during examination that there was another substance, amprenavir, which fell within the scope of the claims and was included in the ARTG.  As amprenavir was registered before darunavir, the extension of term had to be based on the former substance.  It was immaterial that the registration of amprenavir was sponsored by a person other than the patentee.

AbbVie Biotechnology Ltd [2015] APO 45

The earliest regulatory approval date was the date of the goods were first registered, not the date of subsequent inclusions for various different indications.  This decision was affirmed by the AAT in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 at [82]-[89].

iCeutica Pty Ltd [2018] APO 77

The patent included a claim directed to a composition comprising nanoparticles of diclofenac, olanzapine, raloxifene or fenofibrate.  The patentee applied for an extension of term based on a composition comprising nanoparticles of diclofenac.  It was subsequently found that the claims included a composition comprising nanoparticles of fenofibrate which was listed on the ARTG ten years earlier than the composition the subject of the sec 70 application.  The application therefore did not comply with sec 71(2).